BEUDAMED
    FDA Registration Active 🇺🇸 United States

    04.10241S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    18
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics U.S., LLC
    Registration Number
    2029275
    FEI Number
    1000306431
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    344 Bonnie Cir
    City
    Corona
    State
    CA
    ZIP
    92878
    Country
    US

    Regulatory Submissions

    510(k) Number
    K081568

    Owner / Operator

    Firm Name
    Sotera Health LLC
    Operator Number
    10029425
    Address
    2015 Spring Road, Suite 650
    City
    Oak Brook
    State
    IL
    Postal Code
    60523
    Country
    US
    Correspondent
    Karen Whaley-Krumins

    Products

    Device Name Product Code
    Appliance, Fixation, Spinal Intervertebral Body KWQ

    Proprietary Names

    04.10241S 04.10237S 04.10243S 04.10341S 04.10339S 04.10249S 04.10247S 04.10345S 04.10239S 04.10337S 04.10347S 04.10351S 04.10353S 04.10245S 04.10343S 04.10251S 04.10253S 04.10349S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)